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REGULATION: Misconcepts cause high costs and huge delays in regulation of GM-crops
Posted: 24 October 2009 03:14 PM  
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Total Posts:  21
Joined  2005-10-20

1. The issue
The Cartagena Protocol on Biosafety (CPB) has now been adopted by 157 parties http://www.cbd.int/biosafety/signinglist.shtml. It still builds on the principle that GM crop plants might bare risks in contrast to the conventional crops: Objective of CPB http://www.cbd.int/biosafety/articles.shtml?a=cpb-01. The huge apparatus on risk assessment based on this protocol is building on the principle, that the mechanism of transgenicity is totally artificial and is not found in nature. Modern molecular science insights have proven the contrary, as shown in ASK-FORCE AF-9 on the molecular basis of transgenesis. This results in maintaining to an asymmetric risk assessment of innovation of GM crops. The possible exemption of widespread GM crops in Art. 7.4 http://www.cbd.int/biosafety/articles.shtml?a=cpb-07 is not even considered officially up to now.

2. Summary
An excellent summary graph is given in (Graff et al., 2009) in fig. 1b: innovations active in the R&D pipeline were growing at an increasing rate during the period before 1998, but declined after 1998. Apart from competition of reasonably close non-transgenic substitutes the authors consider one regulatory reason to be the main culprit: The halting of regulatory approvals in 1998 in Europe. Although the authors consider the full extent of reasons still to be conjectural, their data suggest that changes in regulatory environment may have been a cause. In a combination of high costs for lost implementation and high costs for regulatory approvals the present state and operational experience has grown into a major obstacle of modern crop breeding.
Commentary from Table 1: The primary survey combined records from scientific publications, field trial records and regulatory filings to identify 558 transgenic plants with quality improvements and determine how far they had progressed through stages of R&D by 2004, including those that had only been published in the scientific literature; those that had reached initial field trials (defined as having completed 1–3 field trials), mid-stage field trials (4–9 field trials) or advanced field trials (>10); those that had entered regulatory filings; and those that were commercialized. The secondary survey canvassed expectations of firms and analysts about the likelihood and time frame for future commercialization of transgenic product quality innovations. Complete one-to-one correspondence between individual observations of the two surveys was not possible.

More details and literature citations in:
http://www.botanischergarten.ch/AF-10-Over-Regulation/AF-10-Over-Regulation-20091220-web.pdf

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Klaus Ammann, Prof. hon. emeritus, Moderator ASK-FORCE EFB
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